Abstract: Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. A valve frame can have a tapered profile when mounted on a delivery shaft, with an inflow end portion having a smaller diameter than an outflow end portion. The valve can comprise generally V-shaped leaflets, reducing material within the inflow end of the frame. An outer skirt can be secured to the outside of the inflow end portion of the frame, the outer skirt having longitudinal slack when the valve is expanded and lying flat against the frame when the valve is collapsed. A diagonally woven inner skirt can elongate axially with the frame. Side tabs of adjacent leaflets can extend through and be secured to window frame portions of the frame to form commissures. The window frame portions can be depressed radially inward relative to surrounding frame portions when the valve is crimped onto a delivery shaft.

Abstract: A docking device includes a hollow cylindrical body portion having an internal surface and an outer surface. The hollow cylindrical body portion is formed of a three-dimensional (3D) woven fabric comprising a plurality of different types of fibers.

Abstract: A prosthetic device, such as a prosthetic heart valve, can include a frame that is radially expandable and compressible between a radially compressed state and a radially expanded state. In some examples, the prosthetic device can include locking mechanisms that are configured to hold the prosthetic device in a radially expanded state. In some examples, the locking mechanisms can be integrated into the frame of the prosthetic device.

Abstract: Embodiments of a prosthetic heart valve are disclosed. An implantable prosthetic valve may be radially collapsible to a collapsed configuration and radially expandable to an expanded configuration. The prosthetic valve may comprise an annular frame, a leaflet structure positioned within the frame and a plurality of outer skirts positioned around an outer surface of the frame, each outer skirt comprising an inflow edge secured to the frame and an outflow edge secured at intervals to the frame. The plurality of outer skirts may include a first outer skirt and a second outer skirt, wherein in the expanded configuration the first and second outer skirts include openings unsecured to the frame between the intervals. The inflow edge of the first annular outer skirt may be secured to the frame with sutures including radiopaque material. The first annular outer skirt may include radiopaque dye.

Abstract: Devices and methods for retrieving percutaneously implanted catheter systems such as a heart valve repair system. The devices include at least one locking connector at the distal end of a flexible elongated extension for coupling to an implanted tubular member. The locking connector may be a tubular anchor having a pair of distal prongs which are biased outward and face in a proximal direction, as well as an expandable auxetic midsection. Inserting the tubular anchor into the implanted tubular member flexes the distal prongs inward such that they prevent proximal movement of the tubular anchor. A user pulls on the proximal end of the tubular anchor to expand the auxetic midsection and lock the two pieces together. The devices and methods are particularly useful to attach extensions to implanted concentric tubes to enable relative axial force application.

Abstract: A method of implanting a balloon expandable prosthetic valve within a native aortic valve includes introducing a delivery system into a femoral artery of a patient, the delivery system comprising an outer sleeve and a shaft extending through a lumen of the outer sleeve. A distal end portion of the shaft is positioned distal to a distal end of a steerable distal end portion of the outer sleeve. A prosthetic valve is crimped over a balloon disposed along the distal end portion of the shaft. The delivery system further comprises a first radiopaque marker inside the balloon and positioned adjacent a proximal end of the prosthetic valve and a second radiopaque marker inside the balloon and positioned adjacent a distal end of the prosthetic valve. The method also includes identifying a location of the prosthetic valve by monitoring the first and second radiopaque markers inside the balloon under fluoroscopy.

Abstract: A system is transluminally advanced into the heart of a subject. A first portion of the system is positioned through a native valve of the heart, the system including wires disposed at the first portion. The first portion is stabilized at the native valve by positioning a distal portion of the system within a blood vessel of the subject. While the distal portion of the system remains within the blood vessel, the wires are induced to bow laterally such that the wires press against the native valve. While the wires remain pressed against the native valve, the shape of the wires is radiographically imaged. An anchor is transluminally anchored to tissue of the native valve, facilitated by the imaging. Other embodiments are also described.

Abstract: A prosthetic heart valve comprises a radially collapsible and expandable annular frame and a leaflet structure comprising three leaflets. Each leaflet has an upper edge portion, a curved lower edge portion and two side flaps, wherein each side flap is connected to an adjacent side flap of another leaflet to form commissures of the leaflet structure, with each commissure being attached to the frame. An annular inner sleeve comprises three U-shaped portions positioned along the curved lower edge portions of the leaflets. An annular outer sleeve extends around are outer surface of the frame, wherein the outer sleeve is made of pericardium. The frame is made of Nitinol and the prosthetic valve can be radially crimped to a radially collapsed configuration inside a sheath for delivery into a patient's body and self-expand to a radially expanded configuration when released from the sheath inside the patient's body.

Abstract: A prosthetic valve delivery apparatus can comprise a handle, an outer shaft extending distally from the handle, a gear mechanism arranged distal to the outer shaft, an input torque shaft extending distally from the handle through the outer shaft and having a distal end portion operatively connected to the gear mechanism, and a plurality of output torque shafts operatively connected to and extending distally from the gear mechanism. The gear mechanism is configured to transfer rotational motion from the input torque shaft to the plurality of output torque shafts.

Abstract: A handle for a prosthetic heart valve delivery apparatus includes a housing, a motorized mechanism, and a holding mechanism. The housing is configured to be hand-held by a user and includes a distal opening. The motorized mechanism is disposed within the housing and is configured to be releasably coupled to a proximal end portion of a first shaft of the prosthetic heart valve delivery apparatus. When actuated, the motorized mechanism is configured to rotate the first shaft relative to the housing. The holding mechanism is disposed inside the housing and is configured to engage a proximal end portion of a second shaft of the prosthetic heart valve delivery apparatus such that the second shaft is axially and rotationally fixed relative to the housing, and the first shaft extends through the second shaft.

Abstract: A handle for a prosthetic heart valve delivery apparatus includes a housing, a motorized mechanism, and a holding mechanism. The housing is configured to be hand-held by a user and includes a distal opening. The motorized mechanism is disposed within the housing and is configured to be releasably coupled to a proximal end portion of a first shaft of the prosthetic heart valve delivery apparatus. When actuated, the motorized mechanism is configured to rotate the first shaft relative to the housing. The holding mechanism is disposed inside the housing and is configured to engage a proximal end portion of a second shaft of the prosthetic heart valve delivery apparatus such that the second shaft is axially and rotationally fixed relative to the housing, and the first shaft extends through the second shaft.

Abstract: An assembly for replacement of a native aortic heart valve includes a radially collapsible prosthetic heart valve and a delivery apparatus. The prosthetic heart valve includes an annular frame with attachment posts, wherein each of the posts has an axial post portion and a transverse post portion having a greater circumferential dimension than the axial post portion. The delivery apparatus includes an inner shaft with a valve connection portion for releasably coupling to the attachment posts and an outer shaft having a sheath for maintaining the prosthetic heart valve in a radially compressed state. Rotation of a control knob on a handle causes the sheath to retract for uncovering a portion of the prosthetic heart valve. Further rotation of the control knob allows the posts to decouple from the delivery apparatus such that the prosthetic heart valve self-expands to a fully expanded state.

Abstract: An implantable prosthetic device includes a plurality of anchor members, a plurality of clasps, and a cover. The plurality of clasps are configured to capture the leaflets to secure the leaflets to the anchor members. The cover is disposed over the plurality of anchor members. The cover can also be disposed over the clasps and a spacer member. A portion of the cover can be covered by a coupler. One or more extensions of a coupling collar can extend through the cover.

Abstract: An improved holder and storage system for prosthetic heart valves that pre-shields or pre-constricts the commissure posts of the valve to prevent suture looping. Pre-shielding and pre-constriction mean at the time of manufacture, so that the valves are stored with the commissure posts shielded and/or constricted. The holders may have solid legs that directly contact and constrict and hold the commissure posts without the use of sutures in tension that might creep over the time in storage. The holder may have a base in contact with the inflow end and a shaft portion that projects through the valve leaflets and cooperates with movable legs on the outflow end of the valve in contact with the commissure posts. The holders may, alternatively, have flexible leg members that extend through the valve and have distal end portions configured to extend over and shield the tips of commissure posts.

Abstract: Prosthetic heart valves are described. Prosthetic heart valves can include radially expandable and compressible inner and outer metal frames. The inner frame can be disposed within a lumen of the outer frame and can be coupled to the outer frame. An outflow end of the inner frame can be coupled to and/or located at an outflow end of the outer frame. An end portion of the inner frame can be spaced radially inwardly from an inner surface of the outer frame, such that a radial gap exists between the inner surface of the outer frame and an outer surface of the inner frame. Prosthetic heart valves can further include a plurality of leaflets disposed within and supported by the inner frame, such as by commissure posts of the inner frame.

Abstract: A method of replacing the function of a native heart valve is achieved by inserting a distal end portion of a delivery apparatus into a patient's body, wherein a prosthetic valve is disposed along the distal end portion of the delivery apparatus. The prosthetic valve includes a collapsible and expandable annular body having a network of struts interconnected at a plurality of nodes to form a plurality of open cells. Atrial and ventricular flanges are coupled to the annular body and extend radially away from the annular body. The annular body includes three commissure support posts of fixed length that extend substantially the entire length of the annular body. A valve member is secured to the commissure support posts. The annular body is radially expanded within the native heart valve and the atrial and ventricular flanges are deployed on opposite sides of the native heart valve.

Abstract: A crimping device for a prosthetic heart valve can comprise an annular outer frame and an inner frame extending through the outer frame, the inner frame comprising first and second axial end portions and a plurality of jaw guides extending therebetween, where the inner frame defines a central opening extending therethrough. The crimping device can comprise a plurality of jaws operatively coupled to the inner and outer frames, each jaw having an inner portion positioned within the central opening of the inner frame and an engagement portion configured to slide along a respective jaw guide, each jaw guide comprising an inclined guiderail extending between the first and second axial end portions. Relative axial motion between the outer and inner frames causes radial motion of the jaws for crimping a prosthetic device positioned within the central opening.

Abstract: An implantable prosthetic device such as might be used to treat poor function of a diseased heart valve in a medical patient includes a body portion and an anchor portion including a plurality of paddles. Clasps attached to the paddles include fixed arms and moveable arms operable to secure the device to the patient's native valve leaflets.

Abstract: A monitoring system includes a wearable patch device configured to be secured to a body of a patient, the wearable patch device comprising a patch body, a first discrete transducer associated with a first position of the patch body, a second discrete transducer associated with a second portion of the patch body, and a wireless transmitter, and electronics including one or more processors and one or more memory devices and configured to receive signals based on transducer readings of the first and second discrete transducers and determine an amount of blood flow through one or more valves of a heart of the patient based on the signals.

Abstract: A method for improving leaflet prolapse and/or valve regurgitation associated with a heart valve involves delivering a spacer device into a ventricle of a heart using a delivery system comprising a catheter, fixing the spacer device to a wall of the ventricle, expanding the spacer device to reposition a papillary muscle disposed in the ventricle away from the wall, the papillary muscle being connected to a leaflet of an atrioventricular heart valve via chordae tendineae, and releasing the spacer device from the catheter.